CurrentCentenePolicy CP PCH.41

Clinical Policy: Dimethyl Fumarate (Tecfidera), Diroximel Fumarate (Vumerity), Monomethyl Fumarate (Bafiertam)

Defines clinical prior-authorization criteria, continued therapy requirements, dosing limits, contraindications, and formulary redirections for Tecfidera, Vumerity, and Bafiertam for treatment of relapsing forms of multiple sclerosis in adults for Centene lines of business (Commercial, HIM).

Policy Summary

PayerCentene

PolicyClinical Policy: Dimethyl Fumarate (Tecfidera), Diroximel Fumarate (Vumerity), Monomethyl Fumarate (Bafiertam)

Policy CodePolicy CP PCH.41

Change TypeAnnual reviews and template/requirement revisions

Effective DateFeb 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation (office notes, labs, baseline relapses per year and EDSS) showing member meets all approval criteria.

POLICY UPDATE CHANGES

Added Bafiertam to policy and retired CP PHAR.460.

Revised redirection and requirement language for Vumerity requests to require generic dimethyl fumarate, Aubagio, Gilenya, and either an interferon-beta agent or glatiramer for RRMS.

Clarified that requirement for medical justification that generic dimethyl fumarate cannot be used applies only to brand Tecfidera requests.

Template changes applied to other diagnoses/indications and continued therapy section.

Revised continued approval duration language to reference duration of total treatment received rather than number of re-authorizations to be inclusive of members continuing therapy from a different benefit.

3Drugs covered by policy

18+Minimum age (years)

Initial approval duration (months)

Coverage Summary

Defines clinical prior-authorization criteria, continued therapy requirements, dosing limits, contraindications, and formulary redirections for Tecfidera, Vumerity, and Bafiertam for treatment of relapsing forms of multiple sclerosis in adults for Centene lines of business (Commercial, HIM). Coverage stance: covered_with_criteria. Status: CURRENT. Subject: Dimethyl fumarate (Tecfidera), Diroximel fumarate (Vumerity), Monomethyl fumarate (Bafiertam). Effective date: 02.01.21; Last review date: 05.23.

Key thresholds and quick facts

Drugs covered by policy3

Minimum age18+ years (>= 18 years)

Initial approval duration6 months

Age threshold (policy threshold)>= 18 years

Starting dose duration7 days

Initial Therapy Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of one of the following: clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS), or active secondary progressive multiple sclerosis (SPMS).
Prescribed by or in consultation with a neurologist.
Member is >= 18 years of age.>= 18 years
Requested agent is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D).

Continued Therapy (Renewal) Criteria

Covered when ALL of the following are met:

ref

Diagnoses / Indications NOT Authorized

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Tecfidera, Vumerity, and Bafiertam and for all disease-modifying therapies for multiple sclerosis. Providers must submit supporting documentation (office chart notes, laboratory results, or other clinical information) showing the member meets all approval criteria.

Include office notes and relevant labs demonstrating diagnosis and baseline/ongoing assessments.

Documentation Required

Baseline documentation required

At the time of the initial request, the provider must document the baseline number of relapses per year and the Expanded Disability Status Scale (EDSS) score for the member.

Applicable Codes

No specific procedure or drug codes listedmixed

No codes listed

Clinical Evidence & Guidance

Guideline support: American Academy of Neurology 2018 practice guideline on disease-modifying therapies for adults with MS is cited and was reaffirmed in September 2021.

Prescribing information review: Tecfidera and Vumerity prescribing information were reviewed in September 2022; Bafiertam prescribing information was reviewed in 2021.

Background

Tecfidera (dimethyl fumarate), Vumerity (diroximel fumarate), and Bafiertam (monomethyl fumarate) are nuclear factor erythroid 2–related factor (Nrf2) activators indicated for relapsing forms of multiple sclerosis in adults. Tecfidera and Vumerity are both prodrugs of Bafiertam.

Dosing is specified with a 7‑day starting dose period followed by maintenance dosing: Tecfidera starting 240 mg/day (maintenance 480 mg/day), Vumerity starting 462 mg/day (maintenance 924 mg/day), and Bafiertam starting 190 mg/day (maintenance 380 mg/day).

Formulary positioning: the policy lists preferred therapeutic alternatives (e.g., Aubagio, Gilenya, interferon-beta agents, glatiramer) and directs use of these earlier options or generic dimethyl fumarate prior to brand agents in many cases; interferon and glatiramer products are positioned as earlier options for certain indications.

EDSS (Expanded Disability Status Scale): a standardized scale referenced in this policy for baseline and follow-up assessment of disability in multiple sclerosis.

Revision History

01.11.21created

Policy created (Commercial and HIM separated from CP PHAR.249); clarified that requirement for medical justification that generic dimethyl fumarate cannot be used applies only to brand Tecfidera requests; removed redirection to Mayzent and modified Vumerity redirection language per SDC/clinical guidance.

02.08.21annual_review

2Q 2021 annual review added Bafiertam to the policy, retired CP PHAR.460, and revised medical justification language to require use of the generic product.

02.07.22annual_review

2Q 2022 annual review: no significant clinical changes; clarified interferon-beta product redirections for each line of business per SDC; references reviewed and updated.

Policy Summary

PayerCentene

PolicyClinical Policy: Dimethyl Fumarate (Tecfidera), Diroximel Fumarate (Vumerity), Monomethyl Fumarate (Bafiertam)

Policy CodePolicy CP PCH.41

Change TypeAnnual reviews and template/requirement revisions

Effective DateFeb 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation (office notes, labs, baseline relapses per year and EDSS) showing member meets all approval criteria.

On This Page

For brand Tecfidera requests, member must use generic dimethyl fumarate unless contraindicated or clinically significant adverse effects are experienced.

Applies to brand Tecfidera only.

Documentation of baseline number of relapses per year and Expanded Disability Status Scale (EDSS) score.

Dosing limits

Starting dose for up to 7 days: Tecfidera 240 mg/day (120 mg PO BID), Vumerity 462 mg/day (231 mg PO BID), or Bafiertam 190 mg/day (95 mg PO BID).7 days
Maintenance dose: Tecfidera 480 mg/day (240 mg PO BID), Vumerity 924 mg/day (462 mg PO BID), or Bafiertam 380 mg/day (190 mg PO BID).

For requests for Vumerity or Bafiertam - one of the following pathways must be met

Member is contraindicated to both, or has experienced clinically significant adverse effects to one, of the following at up to maximally indicated doses: an interferon-beta agent (Avonex, Betaseron/Extavia, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa).
Or failure of ALL (required) unless contraindicated or adverse effects
- Failure of generic dimethyl fumarate (generic Tecfidera) at up to maximally indicated doses.
- Failure of Aubagio (teriflunomide) at up to maximally indicated doses.
- Failure of Gilenya (fingolimod) at up to maximally indicated doses.
- Failure of an interferon-beta agent or glatiramer at up to maximally indicated doses.

Documentation Required

Continued therapy documentation

For renewal, the provider must document either a positive response to therapy or provide medical justification that continued benefit is expected. Positive response includes: no increase in number of relapses per year compared to baseline, fewer than 2 new MRI‑detected lesions, and no increase in EDSS score from baseline.

Billing Rule

Brand-to-generic redirection

Brand Tecfidera requests (and brand-specific rules for Vumerity continued therapy) require use of generic dimethyl fumarate unless the member is contraindicated to or has experienced clinically significant adverse effects from the generic product; documentation of contraindication or adverse effects must be provided.

Denial Risk

Requests for excluded diagnoses will be denied

Requests for primary progressive multiple sclerosis or non–FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation is provided per the applicable off‑label use policies.

Non‑FDA indications require documentation per CP.CPA.09 (Commercial) or HIM.PA.154 (HIM) to be considered.

09.29.22template_change

Template changes applied to other diagnoses/indications and the continued therapy section.

12.15.22applied_change

Added generic redirection for the continued therapy section.

01.31.23annual_reviewLatest

2Q 2023 annual review: revised continued approval duration wording to reference duration of total treatment received (to be inclusive of members continuing therapy from a different benefit); references reviewed and updated.